OBJECTIVES: To investigate the effects of underwater ultrasound (US) therapy in 48 patients with moderately active rheumatoid arthritis (Disease Activity Score in 28 joints (DAS28) > 3.2 and < 5.1). METHODS: Patients randomly assigned to the ultrasound group (n = 25) received underwater continuous ultrasound therapy to both wrists and hands for 7 min per session with an intensity of 0.7W/cm2 for 10 sessions. The control group (n = 23) received sham treatment under the same conditions. At baseline, at the end of treatment (end of week 2) and at the follow-up visit (week 14), the following outcomes were evaluated: disease activity (erythrocyte sedimentation rate (ESR), c-reactive protein (CRP), tender and swollen joint counts, pain on a visual analog scale, DAS28, hand function (fist making, wrist extension and flexion, hand grip strength) and quality of life (Health Assessment Questionnaire (HAQ)). RESULTS: A significant decrease in c-reactive protein at the end of week 2 and week 14 compared to control group (mean between-group difference at 2 weeks -5.77, 95% CI -10.86 to -0.68, mean between-group difference at 14 weeks -5.07, 95% CI -10.13 to -0.01), and non-significant decrease in DAS28 was observed. By the end of treatments at the end of week 2, ultrasound alleviated pain significantly (mean between-group difference at two weeks -8.35 95% CI -16.12 to -0.58), as well as improved left wrist extension compared to the control group (mean between-group difference at 14 weeks 4.35, 95% CI 1.09 to 7.60). CONCLUSION: Underwater ultrasound therapy was better than sham treatment at the end of 2 weeks of treatment, but not at long term (14 weeks) in patients with rheumatoid arthritis. CLINICAL TRIAL REGISTRATION NUMBER: NCT02706028 (https://ClinicalTrials.gov/ct2/show/NCT02706028).

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